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NCT02000427 · ClinicalTrials.gov registry record · Phase 2
Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia
A Phase 2 study of Relapsed/Refractory Philadelphia Positive B-precursor ALL, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 20
- Study locations
NCT02000427: Completed Phase 2 study of Relapsed/Refractory Philadelphia Positive B-precursor ALL, sponsored by Amgen.
NCT02000427 is a Phase 2 study of Relapsed/Refractory Philadelphia Positive B-precursor ALL that has completed, run by Amgen. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02000427, a Phase 2 study of Relapsed/Refractory Philadelphia Positive B-precursor ALL, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective is to evaluate the rate of complete remission/complete remission with partial hematological recovery (CRh\*) in adults with relapsed/refractory Philadelphia chromosome positive (Ph+) B-precursor acute lymphoblastic leukemia (ALL) who receive blinatumomab.
Primary Outcome
Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts. Complete remission was defined as meeting all 3 of the following criteria: * less than or equal to 5% blasts in the bone marrow; * no evidence of disease * full recovery of peripheral blood counts: platelets \> 100,000/μl, and absolute neutrophil count (ANC) \> 1000/μl. Complete remission with partial hematological recovery (CRh\*) was defined as
Conditions Studied
Interventions
- DRUG Blinatumomab
Study Locations (20)
Other
- Research Site - Nantes
- Research Site - Paris
- Research Site - Toulouse
- Research Site - Berlin
- Research Site - Essen
- Research Site - Frankfurt am Main
- Research Site - Würzburg
- Research Site - Bergamo
- Research Site - Bologna
- Research Site - Roma
- Research Site - Venezia
- Research Site - Verona
California
- Research Site - Duarte
- Research Site - La Jolla
Georgia
- Research Site - Atlanta
Minnesota
- Research Site - Rochester
Missouri
- Research Site - St Louis
New York
- Research Site - New York
North Carolina
- Research Site - Durham
Texas
- Research Site - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2014-01-03 |
| Est. Completion | 2017-01-06 |
| Phase | Phase 2 |
What the finished NCT02000427 record still lists
NCT02000427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Relapsed/Refractory Philadelphia Positive B-precursor ALL appearing as the primary indexed condition, and to 1 intervention - of which Blinatumomab is the first listed.
NCT02000427 names 20 study sites across 8 states, led by Other, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT02000427 about?
NCT02000427 is a clinical study titled "Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia". The primary objective is to evaluate the rate of complete remission/complete remission with partial hematological recovery (CRh\*) in adults with relapsed/refractory Philadelphia chromosome positive (Ph+) B-precursor acute lymphoblastic leukemia (ALL) who receive blinatumomab.
What is the current status of trial NCT02000427?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2014-01-03. Estimated completion is 2017-01-06.
What conditions does trial NCT02000427 study?
This clinical trial studies the following conditions: Relapsed/Refractory Philadelphia Positive B-precursor ALL.
What interventions are being tested in trial NCT02000427?
The interventions under investigation include: Blinatumomab (DRUG).
Who is sponsoring clinical trial NCT02000427?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02000427 being conducted?
This trial has 20 study locations across California, Georgia, Minnesota, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02000427's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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